Computer accessible methods for establishing informed consent

ABSTRACT

A method for establishing certifiable patient informed consent for a medical procedure, where, in one embodiment, the patient interacts with a video training system until mastery of all required information is successfully achieved. Training techniques which permit elicitation of measurable behaviors from a patient as a guide to discerning the level of knowledge of the patient are utilized. Certification is only granted when the measurable behavior approximately coincide with the legal and medical standards for establishing informed consent. The system is capable of adapting to various medical procedures, as well as various patient attitudes and knowledge bases, while still maintaining a level of consistency throughout. In one embodiment, a minimum probability of understanding may be preset, and the training procedure will continue until the actual statistical probability of understanding is at least equal to the preset minimum. An interactive nature of the system is present in the present system for facilitating the training process and continuously monitoring the patient&#39;s knowledge.

[0001] This is a continuation of an application filed Jul. 31, 1998entitled “Methods for Establishing Certifiable Informed Consent for aProcedure” bearing Ser. No. 09/124,859, to be issued as U.S. Pat. No.5,999,909, which is in turn a continuation application of an applicationfiled on May 19, 1992, entitled: “Methods for Establishing CertifiableInformed Consent for a Medical Procedure” bearing Ser. No. 07/886,384,now issued as U.S. Pat. No. 5,799,282, each hereby incorporated byreference.

I. FIELD OF THE INVENTION

[0002] The present invention relates to methods for establishinginformed consent to a medical procedure, particularly for medicalprocedures such as a hysterectomy, a blood transfusion, AIDS/HIVtreatment, psychiatric treatment, dental procedures, anesthesia, and thelike. More specifically, the present invention relates to interactivemethods for establishing within a predetermined probability that apatient, or his/her guardian, has understood the disclosed informationregarding the medical procedure.

II. BACKGROUND OF THE INVENTION

[0003] Virtually every medical procedure performed in the United States,including psychiatric treatment and dental procedures, requires that thepatient consent to the procedure. This consent may either be expressedor implied. A competent adult patient can implicitly consent to aprocedure by his/her situation or his/her actions. Examples of this typeof consent would include certain emergencies and typical physicalexaminations. Consent to such procedures is implied by the patient.While it is frequently deemed acceptable, it is not the type of consentpreferred by the medical community and is to be avoided where possible.

[0004] Expressed consent is preferred by the medical community. Atpresent, expressed consent is usually oral or written. The inherentdifficulty in proving details with respect to oral consent makes thistype of expressed consent less preferable for most health careproviders. Using existing techniques, many non-emergency type surgicalprocedures require the patient to read and sign an “informed consent”form. Admittedly, this can be awkward; it is well established, however.For example, the “Operating Room Administration Manual-Checklists,Guidelines & Forms” includes a checklist of clauses which may beincluded in the typical written consent form. In addition, a list ofmedical procedures requiring full disclosure is included as Exhibit 30-3to this reference. These procedures, among many others, are deemed torequire not merely consent, but informed consent.

[0005] The author of an article discussing surgical informed consentsuggests to establish legally-sufficient informed consent, at leastthree elements are required: (1) sufficient information inunderstandable terms, (2) competence on the part of the patient toreason, and (3) absence of coercion. (This reference, disclosed below,contains much authoritative material on the subject of informedconsent.)

[0006] These legal requirements can be burdensome to the medicalpractitioner. Not only does complying with such requirements take time,but the constantly changing state of the law makes merely remainingcurrent in this developing field a challenge. When properly fulfilled,it is even possible that the health care provider could spend more timeobtaining consent to avoid lawsuits than practicing medicine. Thepresent invention is designed to alleviate this imposition on medicalpersonnel by providing a method of establishing certifiable informedconsent. The disclosed system and methods improve the ability ofachieving an “informed” state, the credibility of having received“consent”, and enhance the ability to prove in a court of law thatinformed consent was indeed established, should it be necessary.

[0007] For many years the only device used to indicate possible informedconsent was a standard form, as mentioned previously. In some instancesthe form served as a reference guide for the practitioner as he/she readfrom it to the patient. In other instances the form might have beenhanded to the patient along with a multitude of other forms, eachrequiring the patient's signature. It is very likely that, in haste,many of these informed consent forms are signed without ever having beenread; even more likely is the fact that such forms are rarely trulyunderstood by the patient. One study has shown that on the averagepatients read 4.6 grade levels below their reported highest gradecompleted. The mean reading level in some communities was reported aslow as third grade, with consent forms requiring a post college readinglevel (Southern Medical Journal, October 1991, vol. 84, p. 1172). Thiscombined with the possible recklessness on the part of the patient, aswell as the medical provider, fueled by the litigious nature of oursociety, has contributed to the skyrocketing malpractice insurance feesexperienced by many health care providers. These are, naturally, passedon to the patient in the way of higher medical fees charges. Mostacutely however, the signed informed consent form technique has failedin its primary purpose. Often it has not been deemed to sufficientlyestablish true “informed consent” by the patient.

[0008] To overcome this potential impact, written forms are oftenaccompanied by a verbal explanation or interview by the health careprovider. This solution is undesirable for at least two reasons. First,it reintroduces the oral element in obtaining a consent. Second,unfortunately, informed consent interview techniques are not an areafocused upon by most medical schools. Instead, new practitioners areusually expected to observe, assimilate, and personalize what othercolleagues do. While to a patient this interview may be no lessimportant than the procedure itself, the health care provider may viewit as a bothersome task that has little relevance to the procedure to beperformed.

[0009] Even the standard informed consent forms currently used haveoften fatal practical limitations. They can be inconsistently applied.Typically the forms are modified for each specific medical, dental orpsychiatric procedure. While this is efficient, it rarely takes intoaccount the impacts of the differing information to be conveyed, thediffering manners in which it must be delivered (if read), and thediffering attitudes of the patient. Each of these naturally affect thedependability of the form. In addition, as each doctor tries to alter ageneral form for a specific procedure, personal biases can detract fromthe real goal of the process. Even if each of these limitations wererecognized, until the present invention, it simply would not have beenpractical to tailor a document not only doctor to doctor, but also fromday to day, and from patient mood to patient mood. This latteraspect—that a given patient might have different needs from day to dayor hour to hour—has been an aspect that, until the present invention,those skilled in the art could not readily address. Those skilled in theart, the doctors and lawyers, simply believed it was not possible toaccommodate the needs (if the patient to this degree. While the need forcontrolled consistency in this area has been openly sought by consumerprotection groups, medical groups, and malpractice insurance carriers,until the present invention it was not deemed practical to attempt toutilize a technique which could be varied to suit each specificoccasion.

[0010] In order to meet these needs, the present invention utilizestechniques not traditionally applied to the informed consent field.Among these techniques is the use of video technology. The use of videoas a training tool has been known and widely accepted in a number offields. U.S. Pat. Nos. 4,360,345 and 4,907,973, both to Hon, disclosethe use of computer/video systems for teaching health and medicaleducation. U.S. Pat. No. 4,459,114 to Barwick discloses the use of videoto teach communication skills, while U.S. Pat. No. 4,948,371 to Hall hasapplications in law enforcement training and military training. As thepresent invention recognizes, the video system's ability to provideconsistency through controlled presentation can be beneficially appliedto the informed consent field as well. Video tape {VHS or beta) andvideo disk systems have been used in some hospitals, clinics and doctoroffices, functioning to educate patients on a limited number of medicalprocedures. None, however are used to address the very important aspectof certifying or proving the patient had, without question, given his orher informed consent. Given this known use of such a system, it mightinitially be considered surprising that the application of such atechnology to the informed consent field was not recognized. This,however, may be a result of the diverse perspectives of the techniquestraditionally involved.

[0011] The technology of using video as a training aid has been distinctfrom that of establishing informed consent. This is due to the goalsinvolved, and may be highlighted by the goals of “teaching” and“training.” The Oxford English Dictionary defines training as “bringinga person to a desired state or standard of efficiency by instruction andpractice.” Teaching on the other hand, is merely a process of conveyinginformation. While most patients would sit through a short film on therisks and alternatives as related to a hysterectomy, few would view sucha video with the intent of being trained. Merely presenting a videowould not significantly overcome the limitations of the prior art. Forexample, while the entire procedure may be explained in detail, thepatient is capable of “tuning out” certain information—just as he/shemight ignore or overlook the statements of a doctor. In this case themedical practitioner may believe he/she has satisfied his/herresponsibilities when in fact the patient is not truly consenting in aninformed manner. The present invention overcomes this limitation bydevising a method for certifying not only the level of informationconveyed to a patient, but the patient's level of understanding as well.The patient simply cannot be certified by the present invention andstill have failed to understand the necessary aspects of the procedure.

[0012] Another problem with both the informed consent form and standardeducation video is the extent of the information. Too little, or toomuch information can be detrimental to the process of establishinginformed consent. While most systems and forms might hope to err on theside of too much information, this “overkill” may cause a patient tofail to fully comprehend important elements. Naturally, too littleinformation would also fall short on the informed side of the issue.According to a December 1987 article from The American Journal ofSurgery, entitled “Surgical Informed Consent: What It Is and Is Not”, byW. Sterling Edwards, M.D., et al., the courts have utilized two conceptsas guidelines for the degree of information that must be provided to apatient—the professional standard and the lay standard.

[0013] The professional standard has been suggested to require that themedical practitioner disclose what is standard for the community. As themore objective rule, it is used by the majority of jurisdictions. Thelay standard, known also as the material risk standard, has beensuggested to require the practitioner to disclose what any reasonableperson would want to know about the procedure. With respect to what typeof information must be disclosed, the two standards are in agreementthat the information need not be encyclopedic, and that any possibleserious conditions, no matter how remote, should be disclosed. With boththe standard informed consent form and the continuous video type patienteducation system, a patient is virtually locked into the presentationprocess. If it is too much information, the patient must usually endure.If the information conveyed is deficient, it falls to the patient toglean additional information from another source, such as a doctor ornurse. The present invention avoids placing this burden on the patient.Instead, through interaction with the patient, the information providedcan be personalized to the patient's knowledgebase regardless of whichstandard is utilized.

[0014] Documentation of consent is usually not required by law.Obviously, though, if a suit is filed against a practitioner, the moredocumentation available, the better. In many instances, both thepatient's and the doctor's recall of the information presented can bepoor and unreliable. Thus, a signed document may be the only evidence toreliably evidence consent. The question still remains as to whether suchconsent was “informed”, however. Did the practitioner read over allelements of the form? Did the patient? If either party read the form,did the patient understand the various terms used? Naturally, in a merevideo presentation, similar concerns would arise. Prior to the presentinvention, reproducing the events that transpired up to the point ofsignature was very difficult if not impossible.

[0015] The present invention overcomes this limitation to protectingboth parties before consent can be established. The present invention,in its various methods, recognizes and addresses these and otherproblems and overcomes many limitations encountered by those skilled inthe art by bringing together, and bridging the gaps that have existedbetween the legal, medical, consumer and training fields with respect toestablishing certifiable informed consent. Many devices and procedureshave taught education of patients in the area of medical procedures.However, these devices and procedures have typically considered only theconsumer (patient) groups and the medical field. Other approaches havetaken the perspective of the legal field in attempts to protect medicalpractitioners and their insurance carriers. Until the present invention,no one had-taken the approach of training and certifying patients'knowledge in a pending medical procedure, despite the long felt need forsuch certification, and the existence of the necessary implementingarts. Certainly problems such as proving “informed consent” exist in thefield of informed consent (it might not be such a heavily litigatedfield otherwise), but such problems have gone unnoticed by those skilledin the art. Basically attempts at establishing patient informed consentwere inadequate because those skilled in the art failed to address andbalance the needs of the patient, the doctor, the court system, and theinsurer. The recognition by the present inventors that the problemsencountered in the informed consent field could be solved by applyingand modifying techniques of a training nature, and not an educationalnature, lead to the present invention. While other aspects of thesetraining techniques have been known for some time, and while they havebeen used in various other fields, those skilled in the art ofestablishing informed consent have failed to recognize their value assolutions in the informed consent field. The prior art has taught awayfrom the present invention by stressing education of patients ratherthan training. Other areas of teaching away by the prior art are rootedin the desire for a single general form, rather than a process whichadapts to the continuously varying characteristics of procedures,doctors, patients, and courts. Rather than supplying a system whichaffords only an incremental increase in performance and design over theprior art, the present invention utilizes techniques which were notpreviously considered to achieve leaps in performance compared to theprior art.

III. SUMMARY OF THE INVENTION

[0016] The present invention discloses methods for establishing patientinformed consent in conjunction with most medical procedures, such asused in hospitals, clinics, and doctors' offices. The disclosed methodsprovide a reliable and effective means for certifying each patient'slevel of understanding with respect to information furnished on apending medical procedure. This invention serves to establish apatient's consent to a medical procedure by applying trainingtechniques, to facilitate learning, and to monitor the state ofknowledge by providing an interactive system.

[0017] In general terms, the invention involves various embodiments of atraining technique for certifying informed consent. Many of the steps ofthis procedure achieve several different objects which, when combined,act to achieve the mentioned leaps in performance. In one instance, theinvention takes into account legal and medical requirements forestablishing informed consent while providing an interactive trainingprocess to allow optimal comprehension by the patient. The invention mayalso involve periodic testing which permits the patient's knowledge tobe confirmed and correlated against predetermined minimums forunderstanding. Still other features of the present invention includeclosed-loop testing, which allows for the realization of thepredetermined minimums, and various training media.

[0018] Accordingly, the present invention provides a method whichestablishes certifiable patient informed consent. It acts to provideboth medical practitioners and patients with a competent trainingsystem. The system may include an interactive video disk which mayinteract with the patient through question and response techniques whichhelp to elicit measurable behaviors from the patient. In addition,accepted medical and legal standards can be used to establish parametersin the system.

[0019] It is therefore broadly an object of the present invention toestablish certifiable patient informed consent for a medical, dental orpsychiatric procedure. A system may be designed which utilizesscientific training methods as a basis for interacting with the patient.By using these training methods, the patient's level of knowledge in thevarious areas of the procedure may be monitored. Consequently, eachpatient can be certified as having understood, within a predeterminedprobability, and consented appropriately to the medical procedure. Inaddition, medical and legal standards for establishing informed consentare typical reference parameters considered as the system is designed.

[0020] It is another object of the present invention to design a systemwhich is capable of training a patient on various aspects of a medicalprocedure in an attempt to certify a patient's informed consent. Aclosed-loop system is used so that any patient not achieving the desiredlevel of understanding continues to be trained until such a level isachieved. It is therefore an object of the present invention toperiodically test the patient's knowledge of the conveyed information.The purpose of this periodic testing is to force the patient to provetheir understanding of the information.

[0021] It is still another object of the present invention to elicitfrom the patient various measurable behaviors which may be correlated tothe medical and legal standards utilized for establishing informedconsent. This may be achieved by the periodic testing, mentionedpreviously, which may incorporate any type of question and responseformat, such as, but not limited to, multiple choice, true/false oressay. Likewise, the interactive nature of the system may beaccomplished by numerous types of training media.

[0022] It is yet another object of the present invention to provide asystem which is capable of certifying or proving the patient's level ofknowledge. The present invention achieves this by capturing thepatient's responses, and storing these responses. By doing so, anyquestions as to what the patient understood can be easily recalled andrelated as a probability. In this fashion the invention meets a goal ofcorrelating probabilities to establish a more defensible informedconsent.

[0023] Naturally, further objects of the invention are disclosedthroughout other areas of the specification and claims.

IV. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The following descriptions and referenced drawings are forselected preferred embodiments of the present invention. Naturally,changes may be made to the disclosed embodiments while still fallingwithin the scope and spirit of the present invention and the patentgranted to its inventors.

[0025]FIG. 1 is a flow chart diagram showing one possible embodiment ofthe instructional system development (ISD) process.

[0026]FIG. 2 is a flow chart diagram of another possible embodiment ofthe ISD process.

[0027]FIG. 3 is a flow chart diagram of one possible simplifiedinteraction process of the present invention.

[0028]FIG. 4 is a flow chart diagram of one complex interaction processof the present invention.

[0029]FIG. 5 is a blown-up flow chart diagram of the “presentation ofobjective n” as shown in box A of FIG. 4.

V. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] As can be seen from the drawings, the basic concepts of thepresent invention may be embodied in many different ways. FIGS. 1through 5 show flow diagrams which illustrate different approaches ofthe present invention, in both design and interaction process, tocertify informed patient consent to a medical procedure. The process isdesigned to result in a condition that is sufficient to “certify” thatthe patient was adequately informed when signing a consent form. To“certify” it is intended that a point should be reached by the patientsuch that he/she has achieved at least a predetermined minimum criterionthat the information was understood. Naturally, the minimum would be setat a level consistent with the goals of the present invention. Medicalprocedures are understood to include dental procedures and psychiatrictreatments among others which may require disclosure to the patientbefore beginning. While particular embodiments of the invention will bedescribed, it will be obvious that changes and modifications may be madewithout departing from the broad aspects of the present invention.

[0031] Before beginning the process of certification, requirements andstandards must first be established. The system of the present inventionuses a variation of a known training design and development techniquecalled instructional system development (ISD). ISD is a systematicapproach to the design, development, and continued refinement ofinstruction. The ISD model is explained in detail in a number ofpublished references, including Instructional System Development,printed on Jul. 15, 1986, by the United States Department of The AirForce; Systems Engineering Applied To Training by Silvern, published in1972; The Systematic Design Of Instruction by Dick, et al, published in1978; and, Instructional Product Development by Baker, et al, publishedin 1971. These articles are hereby Incorporated by reference into thediscussion of this application.

[0032] One embodiment of the JSD process used in the present inventionmay be summarized as follows:

[0033] (1) Establish, through analysis, the body of information that apatient might need to know about a particular medical procedure in orderfor them to legally and ethically be considered to be “informed”;

[0034] (2) Establish a set of observable, measurable “objectives” which,if these objectives are achieved or “mastered”, indicate that thepatient comprehends this information and can apply it to his/her ownsituation;

[0035] (3) Develop, for each objective defined in step 2, a set ofinteractive behavioral measures (e.g., questions and patient answers tothese questions) that evaluate whether or not the patient has met theobjective;

[0036] (4) Evaluate the measures developed in step 3 with respect totheir ability to discriminate persons who are knowledgeable about theprocedure from those who are not;

[0037] (5) Develop a sequence of interactive, individualizedinstructions designed to facilitate patients' mastering the objectivesestablished in step 2 (i.e., train them to provide the correct responsesto the measures developed in step 3);

[0038] (6) Evaluate the effectiveness of the instruction and revise theinstruction to correct any deficiencies;

[0039] (7) Implement the interactive sequences developed in steps 2through 6 with actual patients. During the interaction with eachpatient, estimate the probability that the patient has mastered eachobjective. If the probability that the patient has mastered an objectivedoes not meet or exceed a predetermined criterion, present additionalinstruction pertaining to that objective and repeat the evaluation;

[0040] (8) Collect detailed data on actual patients' responses ininteracting with both the instruction and the measures. Use this data torefine both the measures and the instruction.

[0041] ISD, as shown in FIGS. 1 and 2, begins with the “analysis phase.”The development of the present embodiment may be commenced throughcareful evaluation of both legal and medical requirements forestablishing informed consent. Such legal requirements may include,among others, those that are statutorily dictated by state or federalgovernmental bodies, those that have been developed by case law invarious jurisdictions, and those that have been sanctioned by theAmerican Medical Association (AMA) or some other medical field governingbody. The analysis includes evaluating all types of information relevantto a medical procedure and then selecting those items of informationwhich are considered necessary for establishing informed consent. Sincethese requirements may be broadly phrased and ambiguous in meaning, moredefinite parameters may be derived from these requirements. The presentinvention translates requirements into specific statements or standardsdeemed to be representative of the requirements. These may be statementsconcerning patients' knowledge about specific medical procedures,knowledge of the benefits and risks of these procedures, and thepatients' ability to apply this knowledge to their own situation. Forinstance, a court decision may result in new or altered requirements.These new or altered requirements would be translated into one or morespecific standards. As these standards are translated-based on precedentand accepted medical protocol—measurable patient behaviors, orobjectives, may be defined.

[0042] This begins the next step of ISD, called the “design phase.” Inthis phase, objectives are developed based upon the applicablestandards. Each objective specifies the observable behavior(s) thatwould be expected from an informed patient in response to a specificsituation. For example, an objective might state that an informedpatient would, when presented with a list of surgical risks, correctlyrecognize those risks associated with the surgical procedure underconsideration. These objectives, in the present embodiment, are designedto correlate with or approximate as closely as possible the standardsdefined during the analysis phase. The validity of this translation orcorrelation can be evaluated frequently, and the objectives may bealtered or refined to better approximate the estimated standard.

[0043] A second aspect in the “design phase” is to develop, for eachobjective, a set of interactive behavioral measures (e.g., questions andpatient answers to these questions) that evaluate whether or not thepatient has met the objective. These interactions are designed ascriterion-referenced measures. Criterion-referenced measures aredesigned to yield measurements that are directly interpretable in termsof specified performance standards (i.e. Is the respondent capable ofperforming the task represented by the corresponding objective? Does therespondent possess the knowledge required by the correspondingobjective?). They are to be contrasted with the more commonly usednorm-referenced measures (i.e., typical aptitude and achievement tests).The latter are designed to compare respondents with each other to rankthem with respect to a particular set of skills or knowledge.Criterion-Referenced Measurement by James W. Popham, published in 1971,provides detailed discussion on this type of measurement. To supplementthe background of this application the Popham reference is herebyincorporated by reference.

[0044] In the instances and applications of the present invention wherethe defined behaviors are elicited responses to stimuli, such asquestions or statements, a statistical probability can be calculated todetermine whether the objective has been achieved. The calculation maybe as simple as a percentage of correct answers, or may, of course, be amore complex statistical calculation which may take into account aspectssuch as standard variance, normalization, random chance, error analysis,etc. In other instances the predetermined minimum criteria may beachieved to the satisfaction of a training expert, or the like. Inaddition to the ISD model training techniques, the present invention mayalso make use of artificial intelligence techniques for training andevaluation. Each of these techniques is known and implementable by anyperson with reasonable skill in the field of training.

[0045] A third aspect in the “design phase” can be to evaluate thecriterion-referenced items to measure their ability to discriminatepersons who have met the objective from those who have not met theobjective. This may be accomplished through tryouts with two groups ofpersons: one group that can be assumed to be fully informed regardingthe medical procedure (e.g., medical interns, practicing physicians) andone group that can be assumed to be uninformed about the procedure (e.g.high school students). The tryout results for each item could beevaluated as shown in Table I and described below.

[0046] In this hypothetical example, the item being validated has beenadministered to 30 members of each group. Ideally, all members of theGroup A (the “Informed Group”) would answer the item correctly and allmembers of the Group B (the “Uninformed Group”) would answer itincorrectly. In practice, however, an uninformed person may answercorrectly because of an inadvertent clue in the item or a lucky guess.An informed person may answer incorrectly due to a poorly phrasedquestion or through carelessness. TABLE I Informed Uninformed ResponsesGroup Group Totals Correct 27  5 32 p = 27/30 = p = 5/30 = .90 .17Incorrect  3 25 28 p = 3/30 = P = 25/30 = .10 .83 Totals 30 30

[0047] If there is a sufficient difference between the response patternsof the Informed and Uninformed Groups (as there is in this case), theitem is considered to discriminate between groups and is retained.Otherwise, the item is dropped or revised and re-evaluated.

[0048] Naturally establishing even a 100% probability of patientunderstanding of the information provided is not helpful if theinformation provided is not all that is required for the particularmedical procedure. The next step therefore, which begins the ISD“development phase”, is to develop a sequence of interactive,individualized instruction that is designed to facilitate patients'mastering the previously defined objectives and to evaluate theirmastery through the previously developed and calibratedcriterion-referenced measures. The instructional sequence should becomplete and directed explicitly at the objectives, accurate, brief,highly interactive, and capable of adapting to individual patients'requirements, needs, and interests.

[0049] While such a system may seem very simple to develop at first, toinstitute it can require much preparation. This is no more apparent thanin the next step which requires the designing of a system which willinteract with the patient in a controllable fashion in an attempt toelicit the aforementioned measurable behaviors from the patient. Merelyasking the patient, “Do you understand?” to elicit a “Yes” response isno more effective than the standard informed consent form. Instead, theinteraction is designed to force the patient to elicit more affirmativebehaviors to prove an understanding of the selected information. It isbelieved that to do this effectively the training techniques as taughtby the incorporated references are desirable. The reasoning for thisbelief is that while the essential correlation of patient behaviors tolegal and medical standards may be readily established, this is not thecase for the structuring of queries, questions, or basic stimuli basedupon the selected information. The questions must be capable of invokingthe desired behavior from the patient. Furthermore, the presentation ofthe information should be complete, accurate and yet brief so as not toexceed the patient's attention span. Since this is a totally newapplication for these techniques, these sources are hereby incorporatedinto the present application by reference.

[0050] Once legal and medical standards are estimated, behaviorsdefined, information selected, and appropriate stimuli developed thesystem must then be constructed. The preferred embodiment of thisinvention might make use of various forms of computer-assistedinstruction (CAI). This medium provides constant, tireless interactionwith the patient, supports a wide variety of visual and auditorydisplays, is capable of varying the instructional sequence in responseto the patient's actions, and faithfully records each of the patient'sovert responses. In this case, the system 16, would be designed to usestandard computer hardware technology, standard and special purposecomputer software, and video disc or digitized audio and/or video, allof which is known and understood by those skilled in training psychologyand the computer arts.

[0051] The CAI medium may employ text, graphics, still and motion video,and audio in its presentations. The patient may interact with the mediumby typing on a standard keyboard, pressing keys on a simplified key pad,touching parts of the visual display (recognized by means of atouch-sensitive screen), indicating parts of the visual display via amouse, track ball, or light pen, or by answering questions verbally(recognized by voice recognition techniques). The patient may be able toselect the language (e.g., English, Spanish) and the vocabulary levelused in the presentation.

[0052] The CAI instructional sequence may adapt to the patient'srequirements in either or both of two ways. First, the CAI instructionalsequence will provide frequent opportunities for the patient to respondto content-related questions. These questions may be thecriterion-referenced measures described above or they may belower-level, more specific questions that pertain to components of asingle objective. If the patient responds correctly, the program willpresent new material. If the patient responds incorrectly, the programwill review the previously presented material. This review may simplyrepeat the material or it may present it in a different form. Second,the patient may be asked to indicate how the material is to be presented(e.g., language, vocabulary level, sequence of presentation, depth ofpresentation, and if and when to return to a previous part of thepresentation in order to review it).

[0053] The criterion-referenced measures of whether the patient hasachieved the objectives may be embedded in the instructional sequence,may follow the presentation of material of each objective, or may begrouped at the end of the instruction. Alternative forms of the measuresmay also be presented at the beginning of the presentation. In thiscase, the patient's responses to the pre-instruction measures would beused to determine which parts of the instructional sequence should bepresented. This information may be presented to the patient as advice asto which topics to select for instruction or the program may simplyroute the patient to these topics.

[0054] Other learning media may be used of course, such as continuousvideo or audiotape, records, books, and the like, but they can lack theability to interact with the patient and to adapt the instructionalsequence to the patient's needs. In some instances, however, this couldcertainly be an acceptable approach for certifying informed consent.

[0055] In a fourth ISD phase, the system is implemented in the field(e.g., physicians' offices, clinics, hospitals) and put into use withactual patients. Each patient who interacts with the system receives aninstructional sequence tailored to that patient's needs and interests.The anticipated system may be designed to “individualize” the processfor each patient. Foreign languages, allegorical presentations, variousreading and educational levels, and the like may be programmed into thesystem in order to allow a range of individuals to be trained by thesame system.

[0056] During the interaction with each patient, the system willestimate the probability that the patient has mastered each objective.If the estimated probability that the patient has mastered a particularobjective does not exceed a predetermined value, the system will presentadditional instruction pertaining to that objective and repeat theevaluation.

[0057] The close-looped training technique may make use of what is knownby training psychologists as criterion referenced testing. Through theuse criterion referenced testing, acceptable levels of understandingwould be established and the patient would be trained to meet or exceedthese levels. This training and evaluation process is explained in thepaper entitled “An Approach To The Evaluation Of Tailored Testing”,presented by Kathleen M. Daubek and Dr. Wilson A. Judd (a co-inventor ofthe present invention) at the December 1973 annual meeting of the TexasPsychological Association in Dallas, Tex. This paper is herebyincorporated by reference into the present application. In contrast tocriterion referenced testing, most education methods utilize a rankingwhere students are referenced against one another. This is called normreferenced testing. In such a system a score of less than 50% couldbecome an acceptable (passing) level. In the field of informed consent aless than 50% understanding of the risks involved with a certain medicalprocedure would not be very defensible as having achievedan-informed-state. To accomplish the goal of achieving an informedstate, measuring against a predetermined standard—as in criterionreferenced testing—is preferred. This allows the standard level to becontrolled independent of individual scores. Naturally, the higher thelevel, the more repeating is likely to be required, but the moredefensible the certification of informed consent. This level would bebased on the estimated legal and medical standards which apply.

[0058] After the selected information is conveyed to the patient andhe/she exhibits behaviors appropriate to approximately satisfy the legaland medical requirements for establishing informed consent, the patientis then certified. Certification may take a variety of forms, the mostlogical perhaps being a printed “summary of the selected information,questions, and/or responses, or any part thereof, with standard clausesand a signature line for the patient.

[0059] In addition, it is anticipated that the entire interactionbetween the patient and the system could be captured and storedindefinitely. The value of this aspect would be in later deliberationswhich may be expedited if substantial proof could be provided as to thepatient's understanding of the medical procedure at the time of issuinghis/her informed consent. At such a time some form of statisticalanalysis may be provided as to the probability of the patient'sunderstanding of the various aspects of the medical procedure (i.e.,prove achievement of objectives).

[0060] While development of the system is one aspect of the presentinvention, its practical application and use is also key forestablishing certifiable informed consent. As shown in FIGS. 3, 4 and 5the preferred embodiments begin with the training of the patient as tothe various aspects of the required medical procedure. FIG. 3illustrates a simple interactive training procedure, while FIG. 4 isillustrative of a more complex embodiment. FIG. 5, a detailed flow chartof box A of FIG. 4, expands on the complex training procedure, andparticularly the presentation of each objective. The training techniqueis broken down into three steps. First, the patient watches and listensto a brief presentation on the medical procedure. The presentation maysingle out one aspect of the procedure, such as the risks, or it maytouch on all the areas of concern. After this brief presentation thepatient's comprehension of this information is evaluated in the secondstep, as discussed earlier. In this step, a set of queries, questions orstimuli may be presented, and time then allowed for the patient torespond. It is anticipated that the queries could be presented as a setof considerations related to the medical procedure, and whereby thepatient could then react to the considerations by eliciting a behavioralresponse—such as touching the video screen, speaking aloud, or the like.The responses, which are measurable behaviors, are measured toapproximately coincide with the estimated legal and medical standards todetermine the sufficiency of the response. In some cases, responses maybe either right or wrong, and in other cases they may be incomplete—thatis, for example, if a patient is asked to describe three risks ofundergoing the medical procedure as disclosed by the CAI, he/she mayonly be able to remember two. Wrong and incomplete responses may beadequate to determine an insufficient correlation to the estimatedstandards. Statistically speaking, as the number of events (patientsusing the interactive system) increases the measuring of the behaviorsmay be adjusted to achieve better coincidence between the aspectsestablished through the behavioral responses and those required by legaland medical standards.

[0061] The third step involves determining whether the patient'sresponses sufficiently approximate the legal and medical standards forestablishing informed consent—that is, did he/she understand. This maybe accomplished, as mentioned previously, by calculating an actualstatistical probability that an understanding was achieved by thepatient. This probability may then be compared to the predeterminedminimum acceptable probability, as explained earlier. If the actualprobability is greater than the acceptable this would indicate anacceptable condition, and a second training session may be started. If,however, the actual probability is less than the latter, this mightindicate a suboptimal understanding, and require re-training in thisobjective. Re-training would continue with periodic evaluation until atleast the minimum probability of understanding is achieved. Thisclosed-loop training technique will continue until mastery of allaspects presented is achieved by the patient.

[0062] The interactive nature of the present invention facilitateslearning by the patient, and allows continuous monitoring of patients'levels of knowledge. Furthermore, the dissemination of informationthrough CAI is more conducive to a consistent presentation on aday-to-day and even patient-to-patient basis. Even though each patientwill differ in attitude, intelligence, and other personality traits, thesystem will adapt its instruction to assure that almost all if not allpatients achieve at least the minimum level of knowledge established bythe objectives. This relieves the doctor of subjectively trying todetermine if a patient truly understands what has been explained. Thistraining approach serves to remove variance from the informed consentprocedure due to individual human character. The establishment of theinformed consent will be affected by neither a patient's submissivenature, nor a patient's confused state of mind, nor a doctor's busyschedule. Rather, the instructional sequence will present a consistentbody of information in a way that accommodates to each patient's needs.

[0063] Each of the patient's interactions with the system, each overtresponse, and the stimulus to which this response was made will berecorded and stored. This data will then be available for two purposes.First, the complete record of an individual patient's interactions,including their final correct responses to the criterion-referencedmeasures, will be available if a question concerning informed consentshould arise at a later date. Second, as part of the fifth or“evaluation phase” of the ISD process, data from multiple patients willbe used to analyze and refine and improve both the criterion-referencedmeasures and the instructional sequences.

[0064] To better understand the present invention an example of theprocess of one embodiment is discussed. Naturally this is a fictitiousexample, and should not serve to limit the scope of coverage affordedthe patent(s) granted on this invention.

EXAMPLE

[0065] Scenario: Patient A is about to be admitted to the hospital underthe care of Dr. Smith to undergo an abdominal (total) hysterectomy.Before the day of the scheduled surgery Dr. Smith will instruct PatientA to view the disclosure requirements of the procedure on a CAI system(the “invention”). Patient A will agree to view the CAI disclosure.

[0066] Procedure: Patient A will be situated, perhaps in a private roomor waiting area, to begin review of the CAI. Section I/Part 1: Patient Awill be presented background information on abdominal hysterectomies,such as some general information on the medical procedure, and perhapswhy it was probably recommended for her condition. At any time duringpresentation, it may be possible for Patient A to input a command (suchas touch the screen, or press a button) to advance to, or return to aspecific section/part. Section I/Part 2: Patient A will now be presentedwith a variety of open-ended questions, such as:

[0067] List 2 conditions which may require an abdominal hysterectomy?

[0068] What is the average time for an abdominal hysterectomy surgery?

[0069] Which of the following types of anesthesia will you require?

[0070] Section I/Part 3: Patient A will then be encouraged to respond toeach query, and each response evaluated by the system. Patient A answersall three questions correctly. Since no incorrect responses were made,the system estimates that Patient A has mastered this objective andPatient A will then be advanced to the next section.

[0071] Section II/Part 1: Patient A will now be presented with the risksinherent to an abdominal hysterectomy, including undergoing a generalanesthesia. Patient A decides she is well aware of all the risks andadvances the CAI to the next part of the section. Section II/Part 2:Patient A will now be presented with a variety of open-ended questions,such as:

[0072] What are the 4 most common complications of an abdominalhysterectomy?

[0073] What are 3 critical complications of an abdominal hysterectomy?

[0074] Which of the following post-operative discomforts is not typicalfor an abdominal hysterectomy?

[0075] How long is the standard recovery period for an abdominalhysterectomy?

[0076] List 3 minor complications which may be experienced aftersurgery?

[0077] Section II/Part 3: Patient A will again be encouraged to respondto each query, and each response evaluated by the system. Of the fivequestions, Patient A answers four correctly. The question pertaining tocommon complications was answered incorrectly. Patient A will thenautomatically be routed to an alternative description of commoncomplications and an alternative form of the question pertaining tocommon complications will be presented.

[0078] This interactive process may continue for sections on thealternative choices to an abdominal hysterectomy, post-operative care,pre-operative preparation, etc. While the patient may be allowed to skiparound between sections, certification of informed consent will not begranted until Patient A masters (establishes successful achievement of)each objective. Upon mastery of all objectives, the system will print aninformed consent form, listing the key aspects of the interaction,complete with Patient A's name and a signature line, the date and timeof consent, and such information. This may be kept for hospital/doctorrecords, while the complete digital record of the interaction is storedon an internal computer file. Periodically (e.g., monthly) the digitalrecords of all patient interactions will be retrieved from thecomputer's file and archived for some period. Only after completion ofthis procedure, in its entirety, including signing of the form, willPatient A be considered to have given her “informed consent” to theabdominal hysterectomy.

[0079] The preceding discussion and the claims which follow describe thepreferred embodiments of the present invention. Particularly withrespect to the claims, it should be understood that changes may be madewithout departing from its essence. In this regard, it is intended thatsuch changes would still fall within the scope of the present invention.It simply is not practical to describe and claim all possible revisionsto the present invention which may be accomplished. To the extent suchrevisions utilize the essence of the present invention, each wouldnaturally fall within the breadth of protection encompassed by thispatent. This is particularly true for the present invention since itsbasic concepts and understandings are fundamental in nature and can bebroadly applied.

1. A computer accessed and implemented method of establishing certifiable informed consent to an event, said method comprising the steps of: a. estimating legal standards for establishing informed consent of a participant to said event; then b. defining computer measurable participant behavior which can be approximately coincided with said estimated legal standards; then c. accessing a computer system having said computer measurable participant behavior available to it; d. computer training with a first set of instructions said participant on desired aspects of said event through a computer controlled automatic utilization of preprogrammed information stored in a computer; and e. computer interacting with said participant in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable participant behavior said computer measurable participant behavior automatically varying said interaction; and f. automatically computer analyzing said participant behavior; then g. determining whether said training should be adjusted depending on said analyzing said participant behavior; h. identifying which portions of said training should be adjusted; i. modifying to create at least one modified portion of said training to a different set of instructions than said first set of instructions based on said step of determining whether said training should be adjusted; j. additionally computer interacting with said participant in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable participant behavior; and k. additionally computer analyzing said participant behavior; then l. additionally determining whether said training should be adjusted depending on said analyzing said participant behavior; and m. computer providing an automatic indication of certifiability that said participant likely meets said legal standards for establishing informed consent to said event.
 46. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of defining comprises the step of: a. translating said legal standards to computer measurable behavior; then b. evaluating the validity of the correlation between said standards and said behavior.
 47. A computer implemented method of establishing certifiable informed consent as described in claim 46 wherein said step of defining further comprises the step of continuously refining said step of measuring to achieve better approximation between said standards and said computer measurable behavior.
 48. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of computer providing an automatic indication of computer certification comprises the step of achieving defined computer measurable participant behavior which approximately coincide with said legal standards.
 49. A computer implemented method of establishing certifiable informed consent as described in claim 48 wherein said step of computer providing an automatic indication of computer certification further comprises the step of statistically establishing a probability of satisfaction.
 50. A computer implemented method of establishing certifiable informed consent as described in claim 49 wherein said step of statistically establishing comprises the steps of: a. repetitively testing said participant through use of said computer to elicit responses; then b. evaluating said responses through use of said computer.
 51. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of computer providing an automatic indication of computer certification comprises proving mastery of aspects of said event by communicating with said computer.
 52. A computer implemented method of establishing certifiable informed consent as described in claim 51 wherein said step of proving further comprises the steps of: i) storing said computer measurable participant behavior; and ii) providing evidence proving said mastery using said computer.
 53. A computer implemented method of establishing certifiable informed consent as described in claim 1 further comprising the steps of: a. analyzing said event procedure comprising the steps of: (1) compiling fundamental information on said event; then (2) selecting information which may be stored within a computer and which is legally likely to be necessary for informed consent; then b. designing a computer stored system utilizing an instructional system development model for computer training said participant on said selected information.
 54. A computer implemented method of establishing certifiable informed consent as described in claim 53 further comprising automatically periodically performing computer controlled criterion referenced testing on said participant wherein said testing automatically varies said computer controlled presentation.
 55. A computer implemented method of establishing certifiable informed consent as described in claim 54 wherein said step of automatically performing periodic, computer controlled criterion referenced testing comprises the steps of: a. posing a set of applicable considerations to said participant through use of said computer, wherein said considerations relate to said selected information; then b. requiring said participant to respond to said considerations by communicating with said computer.
 56. A computer implemented method of establishing certifiable informed consent as described in claim 1 wherein said step of determining whether said training should be adjusted comprises the steps of: a. predetermining an acceptable statistical probability for indicating a correlation between said participant response and said legal standards; then b. periodically computing an actual statistical probability of said correlation through use of said computer; then c. comparing said actual probability to said acceptable probability through use of said computer; then d. adjusting said training until said actual probability is at least equal to said acceptable probability.
 57. A computer accessed and implemented method of establishing certifiable informed consent for a medical procedure, said method comprising the steps of: a. estimating legal and medical standards for establishing informed consent to said procedure; then b. defining computer measurable patient behavior which can be approximately coincided with said estimated legal and medical standards; then c. accessing a computer system having said computer measurable patient behavior available to it; d. computer training with a first set of instructions said patient on desired aspects of said medical procedure through a computer controlled automatic utilization of preprogrammed information stored in a computer; and e. computer interacting with said patient in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable patient behavior said computer measurable patient behavior automatically varying said interaction; and f. automatically computer analyzing said patient behavior; then g. determining whether said training should be adjusted depending on said analyzing said patient behavior; h. identifying which portions of said training should be adjusted; i. modifying to create at least one modified portion of said training to a different set of instructions than said first set of instructions based on said step of determining whether said training should be adjusted; j. additionally computer interacting with said patient in a standardized fashion through an automatic computer controlled use of preprogrammed information stored in a computer to produce computer measurable patient behavior said computer measurable patient behavior automatically varying said interaction; and k. additionally computer analyzing said patient behavior; then l. additionally determining whether said training should be adjusted depending on said analyzing said patient behavior; and m. computer providing an automatic indication of certifiability that said patient likely meets said legal and medical standards for establishing informed consent to said procedure.
 58. A computer implemented method of establishing certifiable informed consent as described in claim 57 wherein said step of defining comprises the step of: a. translating said legal and medical standards to computer measurable behavior; then b. evaluating the validity of the correlation between said standards and said behavior.
 59. A computer implemented method of establishing certifiable informed consent as described in claim 57 wherein said step of computer providing an automatic indication of computer certification comprises the step of achieving defined computer measurable patient behavior which approximately coincide with said legal and medical standards.
 60. A computer implemented method of establishing certifiable informed consent as described in claim 59 wherein said step of computer providing an automatic indication of computer certification further comprises the step of statistically establishing a probability of satisfaction.
 61. A computer implemented method of establishing certifiable informed consent as described in claim 57 further comprising the steps of: a. analyzing said medical procedure comprising the steps of: (1) compiling fundamental information on said medical procedure; then (2) selecting information which may be stored within a computer and which is legally likely to be necessary for informed consent; then b. designing a computer stored system utilizing an instructional system development model for computer training said patient on said selected information.
 62. A computer implemented method of establishing certifiable informed consent as described in claim 61 further comprising automatically periodically performing computer controlled criterion referenced testing on said patient wherein said testing automatically varies said computer controlled presentation.
 63. A computer implemented method of establishing certifiable informed consent as described in claim 62 wherein said step of automatically performing periodic, computer controlled criterion referenced testing comprises the steps of: a. posing a set of applicable considerations to said patient through use of said computer, wherein said considerations relate to said selected information; then b. requiring said patient to respond to said considerations by communicating with said computer.
 64. A computer implemented method of establishing certifiable informed consent as described in claim 57 wherein said step of determining whether said training should be adjusted comprises the steps of: a. predetermining an acceptable statistical probability for indicating a correlation between said patient response and said legal and medical standards; then b. periodically computing an actual statistical probability of said correlation through use of said computer; then c. comparing said actual probability to said acceptable probability through use of said computer; then d. adjusting said training until said actual probability is at least equal to said acceptable probability. 